Initial Testing of Whole Health STEPS (Structured Tiered Engagement with Peer Support)

Whole Health STEPS 的初步测试（具有同伴支持的结构化分层参与）

• 批准号: 10265541
• 负责人: EMILY JOHNSON
• 金额: --
• 依托单位: SYRACUSE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-10-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10265541
• 关键词: Belief; Caring; Categories; Characteristics; Clinical; Clinical Trials Design; Confidence Intervals; Data; Data Analyses; Data Collection; Development; Diagnostic; Doctor of Philosophy; Drops; Elements; Enrollment; Equipment and supply inventories; Evidence based practice; Feedback; Future; Goals; Health; Health Services; Healthcare; Hour; Individual; Intervention; Interview; Manuals; Mental Health; Mental Health Services; Mental disorders; Methods; Military Personnel; Mission; Modeling; Occupational; Outcome; Outcome Measure; Participant; Patient-Focused Outcomes; Population; Primary Health Care; Process; Process Assessment; Provider; Psyche structure; Psychologist; Psychotherapy; Qualitative Evaluations; Qualitative Methods; Randomized; Randomized Clinical Trials; Recording of previous events; Recovery; Research; Research Training; Role; Self Assessment; Self Management; Self-Direction; Services; Side; Specialist; Structure; Symptoms; Techniques; Telephone; Testing; Time; Training; Training Support; United States Department of Veterans Affairs; Veterans; Vision; Waiting Lists; Well in self; acceptability and feasibility; associated symptom; barrier to care; base; career; design; feasibility research; feasibility testing; flexibility; functional disability; functional outcomes; health care service; health goals; health plan; improved; improved functioning; novel strategies; patient engagement; patient oriented; peer; peer support; primary care setting; primary outcome; psychosocial; retention rate; satisfaction; skills; social; statistics; telephone coaching; tool; uptake; willingness

This RR&D CDA2 will support training for Emily M. Johnson, PhD, as a RR&D research psychologist and develop and evaluate a new package of services, Whole Health STEPS (Structured Tiered Engagement with Peer Support). The training goals for this project are to develop skills in (1) designing and evaluating adaptive stepped care interventions, (2) frameworks for enhancing and evaluating implementation in patient-centered interventions, (3) qualitative methods for enhancing stakeholder engagement and evaluating Veteran engagement in healthcare, and (4) clinical trials design for brief psychosocial interventions. These trainings will support my career focused on patient centered intervention and increasing Veteran engagement in healthcare using methods prioritizing stakeholder engagement.] Whole Health STEPS is an 8-week stepped-care package of four levels of Whole Health services facilitated by a peer support specialist. The four levels include supported self-management (an individual Whole Health STEPS orientation session and use of a self-directed Whole Health tool), brief telephone coaching (weekly 15-minute telephone-based coaching using focused prompts), Whole Health Coaching (weekly hour-long sessions incorporating the full coaching framework), and referral to a higher level of care. Across all levels, Veterans will have brief weekly telephone assessments using the Whole Health Goal Attainment Scale to evaluate progress and inform step-up decisions. Veterans who are not making progress at any of the given levels will be stepped-up to a higher level of care. [The research will involve qualitative stakeholder engagement interviews with primary care peer support staff (n=12), an open trial of Whole Health STEPS (n=10), and a pilot randomized clinical trial (n=44)] with a waitlist control to evaluate the preliminary impact of Whole Health STEPS on reducing functional impairment. [The design also supports further revision of the Whole Health STEPS manual] and evaluates research and intervention feasibility. Specifically, this trial will evaluate feasibility of several aspects of Whole Health STEPS including Veteran satisfaction, peer relationship, intervention retention, fidelity, and appropriateness of the new elements (i.e., the step-up decision points). Further, the design will evaluate research feasibility for a subsequent larger trial including assessment retention and participant willingness to be randomized. The primary patient outcome will be functional impairment evaluated by the Inventory of Psychosocial Functioning. [Stakeholders participating in the interviews will be asked to complete one research interview. Veterans in the open trial will be asked to complete assessments at baseline, after each session, and at the end of Whole Health STEPS.] All Veterans in the pilot RCT will be asked to complete research assessments at baseline, 2 months, and 4 months. Veterans randomized to receive Whole Health STEPS immediately will complete Whole Health STEPS in the first two months. Veterans randomized to the waitlist control will receive Whole Health STEPS between 2 and 4 months. Veterans will be randomized using a stratified permuted block design based on baseline functional impairment. The primary outcome will be evaluated by calculating Cohen’s d effect size at the 2-month assessment point and comparing with a pre-established one-sided confidence interval using a non-central t distribution method. Other quantitative outcome measures will be evaluated with descriptive statistics including means, standard deviations, and confidence intervals. Retention rates will be evaluated using percent of Veterans who withdraw or drop out over time. Qualitative feedback will be evaluated using the Rapid Assessment Process, a qualitative approach designed to provide a rapid but comprehensive qualitative evaluation to interpret and implement changes in a short time frame using triangulation, iterative data analysis, and additional data collection.

该 RR&D CDA2 将支持 Emily M. Johnson 博士作为 RR&D 研究心理学家和 开发和评估一套新的服务，Whole Health STEPS（结构化分层参与） 该项目的培训目标是培养 (1) 设计和评估适应性的技能。 阶梯式护理干预措施，(2) 加强和评估以患者为中心实施情况的框架 干预措施，(3) 增强利益相关者参与和评估退伍军人的定性方法 参与医疗保健，以及（4）针对简短的心理社会干预的临床试验设计。 支持我的职业生涯专注于以患者为中心的干预和提高退伍军人对医疗保健的参与 使用优先考虑利益相关者参与的方法。] Whole Health STEPS 是一个为期 8 周的阶梯式护理套餐 由同伴支持专家提供四个级别的整体健康服务。 支持的自我管理（个人 Whole Health STEPS 定向课程和使用自我指导的 Whole Health 工具）、简短的电话辅导（每周 15 分钟的电话辅导，重点关注 提示）、整体健康辅导（每周一小时的课程，包含完整的辅导框架），以及 转介到更高级别的护理，退伍军人每周都会进行简短的电话评估。 使用整体健康目标达成量表来评估进展并为退伍军人提供升级决策。 在任何给定级别上没有取得进展的人将被提升到更高级别的护理。 研究将涉及对初级保健同行支持人员进行定性利益相关者参与访谈 (n=12)、Whole Health STEPS 的公开试验 (n=10) 和带有候补名单的试点随机临床试验 (n=44)] 控制来评估 Whole Health STEPS 对减少功能障碍的初步影响。 设计还支持进一步修订 Whole Health STEPS 手册]并评估研究和 具体而言，该试验将评估 Whole Health STEPS 几个方面的可行性。 包括退伍军人满意度、同伴关系、干预保留率、忠诚度和新员工的适当性 此外，设计将评估研究的可行性。 随后进行更大规模的试验，包括评估保留和参与者随机分组的意愿。 患者的主要结果将是通过心理社会功能清单评估的功能障碍。 [参与访谈的利益相关者将被要求完成一项退伍军人研究访谈。 公开试验将被要求在基线、每次会议后以及整个试验结束时完成评估 健康步骤。] 试点 RCT 中的所有退伍军人都将被要求完成基线研究评估，2 个月，随机接受 Whole Health STEPS 的退伍军人将立即完成 4 个月。 前两个月随机进入候补名单控制的退伍军人将获得 Whole Health STEPS。 2 至 4 个月之间的健康步骤将使用分层排列区组设计进行随机分配。 主要结果将根据基线功能障碍通过计算 Cohen d 进行评估。 2个月评估点的效应大小并与预先建立的单方面置信度进行比较 使用非中心 t 分布方法来评估其他定量结果指标。 描述性统计数据包括平均值、标准差和置信区间。 将使用随着时间推移退出或退学的退伍军人的百分比进行评估。 使用快速评估流程进行评估，这是一种定性方法，旨在提供快速但 综合定性评估，以在短时间内解释和实施变革 三角测量、迭代数据分析和附加数据收集。